Cytori reaches 75% of target enrollment goal for phase 3 scleroderma trial

Cytori Therapeutics Inc. has announced its phase 3 STAR trial of a fat replacement treatment in the hands of patients with scleroderma has reached 75% of its target enrollment, according to a press release.

The trial is a randomized, placebo-controlled, double-blind, parallel group study designed to assess the efficacy of Cytori Cell Therapy (ECCS-50) injected subcutaneously into the fingers of patients with scleroderma and impaired hand function. Once enrollment is completed, 80 patients will be randomized to either treatment or placebo. After 48 weeks, patients who received placebo will be offered treatment.

“The pace of enrollment has exceeded our original planning and is an indication of the openness and hope from physicians and their patients in the potential for cell therapy as a viable option for scleroderma.” Steven Kesten, MD, chief medical officer at Cytori Therapeutics, said in the release. “Based on screening and scheduling of patients, completion of enrollment will occur by mid-June. We remain exceedingly grateful to the investigators, research staff and especially the patients who have participated.”

According to the press release, none of the 60 fat harvest from small volume liposuction and finger injection procedures completed have resulted in complications. In addition, patients in the pilot trial demonstrated significant improvements in hand function and Raynaud’s syndrome through 2 years after treatment.

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